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The CRISIS Prevention Study (CRISIS)

This study has been terminated.
(Terminated for futility on 11/30/09 based on the recommendation of the DSMB)
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Seattle Children's Hospital
Children's Hospital Los Angeles
Arkansas Children's Hospital Research Institute
Children's Hospital of Michigan
University of Pittsburgh
Children's Research Institute
University of California, Los Angeles
Harborview Injury Prevention and Research Center
Information provided by (Responsible Party):
Michael Dean, University of Utah
ClinicalTrials.gov Identifier:
NCT00395161
First received: October 31, 2006
Last updated: April 16, 2013
Last verified: April 2013
Results First Received: November 14, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Sepsis
Interventions: Drug: Metoclopramide
Drug: Zinc
Dietary Supplement: Glutamine
Drug: Selenium
Other: saline
Other: sterile water
Other: selenium
Dietary Supplement: whey-protein

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Dates of recruitment period: April 2007 - November 2009; Location: Pediatric Intensive Care Unit (PICU)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were stratified according to immunocompromised status prior to randomization.

Reporting Groups
  Description
Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
Enteral Whey Protein, IV Saline Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.

Participant Flow:   Overall Study
    Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide   Enteral Whey Protein, IV Saline
STARTED   149   144 
COMPLETED   149   144 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Daily Nutriceutical Supplementation Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
Whey Protein Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
Total Total of all reporting groups

Baseline Measures
   Daily Nutriceutical Supplementation   Whey Protein   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   144   293 
Age 
[Units: Participants]
     
<=18 years   149   144   293 
Between 18 and 65 years   0   0   0 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 7.9  (5.6)   8.4  (5.9)   8.1  (5.7) 
Gender 
[Units: Participants]
     
Female   69   79   148 
Male   80   65   145 
Region of Enrollment 
[Units: Participants]
     
United States   149   144   293 
Immune Compromised at Study Entry [1] 
[Units: Participants]
     
Immune compromised   14   11   25 
Immune Competent   135   133   268 
[1] Patients were classified as immune compromised if they had acquired immunodeficiency syndrome, cancer, transplantation, primary immune deficiency or chronic immune suppressant therapy.


  Outcome Measures
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1.  Primary:   The Primary Endpoint of This Study is the Median Time Between Admission to the PICU and Occurrence of Nosocomial Infection or Clinical Sepsis in PICU Patients Who Have Endotracheal Tubes, Central Venous Catheters, or Urinary Catheters.   [ Time Frame: 48 hours after admission until 5 days after discharged from the PICU ]

2.  Secondary:   Rate of Nosocomial Infection or Clinical Sepsis Per 100 Study Days   [ Time Frame: 48 hours after PICU admission till discharge from PICU ]

3.  Secondary:   Antibiotic-free Days   [ Time Frame: 48 hours after admission until PICU discharge ]

4.  Secondary:   Incidence of Prolonged Lymphopenia (Absolute Lymphocyte Count Less Than or Equal to 1,000/mm³ for > or Equal to 7 Days)   [ Time Frame: from time of PICU admission till discharge from PICU ]

5.  Secondary:   All-cause 28-day Mortality Rate.   [ Time Frame: 28 days after admission to the PICU ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats


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